Stent-valves for valve replacement and associated methods and systems for surgery

• US 10,314,701 B2
• Filed: 06/23/2017
• Issued: 06/11/2019
• Est. Priority Date: 12/22/2005
• Status: Active Grant

• Current Assignee: Boston Scientific Medical Device Limited (Boston Scientific Corporation)
• Original Assignee: Symetis SA (Boston Scientific Corporation)
• Inventors: Von Segesser, Ludwig K., Delaloye, Stephane
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): Shipmon, Tiffany
• Application Number:
  US15/632,149
• Publication Number:
  US 20180049870A1
• Time in Patent Office: 718 Days
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 17/12031 complete occlusion
• CPC Class Codes: A61B 17/12131 characterised by the type of occluding device
• CPC Class Codes: A61B 2017/00606 Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
• CPC Class Codes: A61B 2017/00623 Introducing or retrieving devices therefor
• CPC Class Codes: A61B 2017/12095 Threaded connection
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2472 Devices for testing
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2002/9505 having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires
• CPC Class Codes: A61F 2002/9534 for repositioning of stents
• CPC Class Codes: A61F 2002/9665 with additional retaining means
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2210/0042 : using a fluid, e.g. circulating
• CPC Class Codes: A61F 2220/0016 : with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0033 : made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2220/0075 : sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2220/0083 : using hook and loop-type fasteners
• CPC Class Codes: A61F 2230/001 : Figure-8-shaped, e.g. hourglass-shaped
• CPC Class Codes: A61F 2230/0013 : Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0067 : conical
• CPC Class Codes: A61F 2230/0078 : hyperboloidal
• CPC Class Codes: A61F 2250/001 : for adjusting a diameter
• CPC Class Codes: A61F 2250/0039 : differing in diameter
• CPC Class Codes: A61F 2250/006 : modular

Abstract

Stent-valves (e.g., single-stent-valves and double-stent-valves), associated methods and systems for their delivery via minimally-invasive surgery, and guide-wire compatible closure devices for sealing access orifices are provided.

Claims

1. A cardiac stent-valve device comprising:

a stent component having a central axis, and an annular groove;

a valve component housed in a section of the stent component;

the stent component and the valve component being configured in a collapsed configuration for delivery at an implantation site, and in a self-expanding expanded configuration after delivery to the implantation site;

wherein;

the stent component comprises a lattice structure including a plurality of cells and a plurality of commissural posts, and a plurality of individual attachment elements projecting integrally from a stent extremity at a first axial end of the stent component,

a commissure between two valve leaflets is attached to a respective commissural post,

each attachment element is configured for removable attachment to a complimentary structure of a delivery system and corresponds to at least a portion of a respective commissural post,

the annular groove is present in the expanded configuration, arranged towards a second axial end opposite the first axial end, and defined by an annular indentation of the stent component which correspondingly presents an indented interior surface of the stent component, and

the valve component extends axially beyond the annular groove towards the attachment elements.

2. The device of claim 1, wherein the cells of the lattice structure are closed.

3. The device of claim 1, wherein in the expanded configuration, the attachment elements project partially radially inwardly toward the central axis of the stent component.

4. The device of claim 3, wherein the attachment elements project partially inwardly toward the central axis on a diameter smaller than a diameter of the section of the stent component housing the valve component.

5. The device of claim 4, wherein the attachment elements are inclined with respect to the central axis to converge towards each other.

6. The device of claim 1, wherein the fully expanded diameter in a region of the attachment elements is smaller than a fully expanded diameter of the section that houses the valve component.

7. The device of claim 1, wherein each attachment element comprises a geometrical opening.

8. The device of claim 1, wherein the number of attachment elements is selected from:

at least three and exactly three.

9. The device of claim 1, wherein the valve component is a tri-leaflet valve.

10. The device of claim 1, wherein an inflow end of the stent component is covered on its inner side with cloth.

11. The device of claim 10, wherein the cloth is sutured to the stent component in a region adjacent to the annular groove.

12. The device of claim 10, wherein the cloth is folded over to the exterior side of the stent component.

13. The device of claim 10, wherein commissures of the valve component are attached to corresponding commissure posts of the stent component that are covered with cloth.

14. A cardiac stent-valve system comprising:

the stent-valve of claim 1; and

a delivery system for delivering the cardiac stent-valve to an implantation site, the delivery system including a stent-holder,

wherein the attachment elements are removably attached to the stent-holder of the delivery system.